CapGenesis Files Five Orphan Drug Designation Requests With the FDA and EMA for CGS-200 as a Topical Analgesic

BETHESDA, MD--(Marketwired - Nov 30, 2015) - CapGenesis Therapeutics, a developer of topical pharmaceutical and consumer healthcare products for site-specific pain, therapeutic dermatologics and orphan disorders, today announced that it has filed five orphan drug designation requests with the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for CGS-200 as a topical analgesic in osteomyelitis, osteosarcoma, osteonecrosis, Paget's disease, and Morton's neuroma.

CGS-200 is a novel, topical formulation of trans-capsaicin which allows for application of capsaicin at concentrations of 1% or higher to be tolerably applied to human skin. Capsaicin is a known agonist of the TRPV-1 channel, which defunctionalizes nerve fibers that transmit pain signals to the brain. Prolonged exposure to capsaicin has been shown to reduce TRPV-1 activity resulting in sustained pain relief. CGS-200 is a proprietary formulation combining varying high concentrations of capsaicin with hyaluronic acid.

Acute osteomyelitis is a serious bone inflammation that can result from a previous trauma and can occur after surgical reduction of bone breaks or joint replacements. Symptoms may include deep localized bone pain or swelling and painful or limited movement of the nearby joints. CGS-200 is being suggested for management of pain arising from osteomyelitis due to post-surgical infections for joint replacement implants, as well surgical reduction of both open and closed fractures of the long bones (femur, tibia, humerus, and radius).

Osteosarcoma is a very rare form of primary bone cancer. Seventy percent of patients with osteosarcoma have regional pain as a symptom; 92% of patients with osteosarcoma have localized tenderness; 39% have painful movement of the affected joint and 23% have restricted movement of the affected joint. The pain of osteosarcoma can be worse at night and can be unremitting.

Osteonecrosis, also known as avascular necrosis, is a disease resulting from the temporary or permanent loss of the blood supply to the bones. Without the blood supply, the bone tissue dies and causes the bone to collapse. If the process involves the bones near a joint, it often leads to collapse of the joint surface. The disease may affect just one bone, more than one bone at the same time, or more than one bone at different times. As the disease progresses, most patients experience joint pain. If osteonecrosis progresses and the bone and surrounding joint surface collapse, pain may develop or increase dramatically. Pain may be severe enough to limit the patient's range of motion in the affected joint.

The bone pain experienced by patients with osteomyelitis, osteosarcoma and osteonecrosis are similar in nature and commonly treated with aspirin and other nonsteroidal anti-inflammatory drugs (NSAIDs), or narcotic analgesics, depending on severity. It has been reported that aspirin and other NSAIDs have little effect on the bone pain associated with osteomyelitis, while narcotic analgesics present risks of present risks of addiction, confusion, nausea, vomiting, constipation, pruritus, respiratory depression, and urinary retention.

Paget's disease is a common bone disorder, however, an estimated 70 percent of patients who have Paget's disease have no symptoms. Patients with bone pain caused by Paget's disease usually describe the pain as continuous. Paget's disease can cause osteoarthritis if the affected section of bone is near a joint. Unlike osteoarthritis, pagetic bone pain usually increases with rest, on weight bearing, when the limbs are warmed, and at night. It is reported that NSAIDs and non-narcotic analgesics have little effect on the bone pain in Paget's disease, leaving narcotic analgesics as the primary treatment option.

Morton's neuroma is a painful condition that affects the ball of the foot, most commonly the area between the third and fourth toes. Morton's neuroma involves a thickening of the tissue around one of the nerves leading to the toes. This can cause a sharp, burning pain in the ball of the foot. Toes may also sting, burn or feel numb. Pain treatments for this condition include injections of anesthetics and or corticosteroids for severe pain and oral NSAIDs for moderate pain, which carry the risk of gastrointestinal ulceration or bleeding; and surgery if these other methods do not provide sufficient relief.

Stanley Pillemer, M.D., Chief Medical Officer of CapGenesis, stated, "We believe previously collected clinical data on the effectiveness of one of our other trans-capsaicin formulations in osteoarthritis suggests that the higher concentrations of capsaicin delivered with CGS-200 has the potential for therapeutic benefits that may add to existing treatments for the pain associated with these debilitating conditions, without deleterious systemic side effects or risks. Our goal is to pursue clinical evidence supporting the approval of CGS-200 in these orphan indications in both the U.S. and European markets."

About CapGenesis TherapeuticsCapGenesis Therapeutics is dedicated to improving the quality of life through developing topical pharmaceutical and consumer healthcare products for site-specific pain, therapeutic dermatologics and orphan disorders. CapGenesis' proprietary pipeline is based on novel formulations of proven, active compounds to enhance efficacy and reduce side effects. The Company's lead program, CGS-125 is in an exploratory study for osteoarthritic knee pain. To learn more about CapGenesis Therapeutics please visit the Company's website at http://www.capgenesis.com/.